Skip to main content
OpenTrials
Completed

NCT Number: NCT01470118

A Study to Evaluate the Duration of LASTACAFT® in Acute Allergic Conjunctivitis

This study will evaluate the duration of action of LASTACAFT® and Pataday™ as compared to artificial tears (placebo) in the prevention of ocular itching associated with allergic conjunctivitis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Conjunctivitis, Allergic Conjunctival Diseases Conjunctivitis Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Philadelphia, Pennsylvania, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • History of eye allergies within the past 24 months
  • Willing to not wear contact lenses at least 72 hours prior to the study start and during the study period

Exclusion criteria

  • Current eye infection
  • Eye surgery within 3 months or vision correction surgery within 6 months
  • Any planned surgery during the study or 30 days after the study

Treatment and study plan

alcaftadine 0.25% ophthalmic solution

Drug

One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.

Other names: LASTACAFT®

olopatadine 0.2% ophthalmic solution

Drug

One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.

Other names: Pataday™

dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%

Drug

One drop of placebo instilled in each eye at Day 0 and Day 14.

Other names: Tears Naturale® II Artificial Tears

Primary outcomes

  1. Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16

    Time frame: Day 0 Hour 16

    Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3) at hour 16. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.

  2. Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24

    Time frame: Day 14 Hour 24

    Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.

Secondary outcomes

  1. Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24

    Time frame: Day 14 Hour 24

    Conjunctival redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored conjunctival redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less conjunctival redness.

  2. Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24

    Time frame: Day 14 Hour 24

    Ciliary redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored ciliary redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less ciliary redness.

  3. Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24

    Time frame: Day 14 Hour 24

    Episcleral redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored episcleral redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less episcleral redness.

  4. Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24

    Time frame: Day 14 Hour 24

    Chemosis evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored chemosis on a numeric analog scale ranging from 0=None to 4=Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less chemosis.

  5. Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24

    Time frame: Day 14 Hour 24

    Eyelid swelling evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored eyelid swelling on a numeric analog 4-point scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less lid swelling.

  6. Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24

    Time frame: Day 14 Hour 24

    Tearing evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored tearing on a 5-point numeric analog scale ranging from 0=None/Normal to 4=Very Severe. For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less tearing.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Nov 11, 2011
Registry last updated
Feb 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.